Type
Full-time
Work mode
On-site
Level
Staff
Industry
Other
Salary
Thương lượng
Location
Hà Nội, Hà Nội, Hà Nội
Overview
- The Regulatory Affairs & Pharmacovigilance (RA/PV) Executive is a dual-capacity role critical to securing and maintaining the Company's license to operate. The executive is responsible for ensuring compliance with all local pharmaceutical registration regulations, particularly with the Drug Administration of Vietnam (DAV), while also safeguarding patient safety by establishing, managing, and…
- System Setup & Compliance: Implement and maintain the Pharmacovigilance System to ensure all products comply with local, national, internal, and external partner requirements.
- Adverse Event Processing: Translate, process, and reconcile adverse event reports, ensuring timely entry into the Global Safety Database and submission of ICSRs to local Health Authorities.
- Safety Training & Audit Readiness: Deliver PV training to staff and vendors and manage audit/inspection preparations to ensure continuous compliance and readiness.
- Risk Management & Escalation: Identify, escalate, and resolve safety and risk compliance issues, serving as a local Deputy QPPV and providing back-up coverage to the PV Country Lead.
- Dossier Preparation & Review: Evaluate, review, and compile high-quality drug registration dossiers for timely and accurate submissions to the DAV.
- Regulatory Authority Relations: Establish and maintain collaborative relationships with the Ministry of Health (MOH) and DAV to facilitate smooth registration activities and resolve query letters.
- Commercial & Tender Support: Review artwork, approve marketing brochures, and coordinate with the tender team on Brand Name and EU GMP listings.
- Compliance Tracking: Monitor DAV regulations, circulars, and guidelines while tracking submission, approval, and registration timelines.
Benefits
Training
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